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Quality Manager

Katalyst CRO

Role overview

Qualifications

  • Medical Device Quality Management Systems (QMS)
  • CAPA, Nonconformance, Complaint, and Audit Management
  • FDA 21 CFR Part 820/QMSR and ISO 13485
  • Risk Management and Design Controls

Responsibilities

  • Lead QMS, CAPA, Nonconformance, Complaint, and Audit programs
  • Support FDA inspections and regulatory audits
  • Drive quality remediation and compliance initiatives
  • Monitor quality metrics and management reviews

Key facts

Hard skills

Other skills

  • Leadership

About the company

Katalyst CRO logo

Katalyst CRO

Contract Research Organizations (CRO)

Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. With a strong foundation in cGxP & ICH-GCP-compliant clinical research, we offer fully customizable, end-to-end solutions, covering everything from pre-clinical studies to Phase I–IV clinical trials, regulatory affairs, and validation services—ensuring seamless drug and device development. Our Expertise Across the Product Lifecycle: 🔹 Pre-Clinical Research & Development – In-Vitro (Lab-Based) & In-Vivo (Animal) Studies 🔹 Clinical Research & Development – Trial Management, Data Management, Biostatistics, Medical Writing, Pharmacovigilance 🔹 Regulatory & Quality Compliance – cGxP (GMP, GLP, GCP) Validations, Regulatory Affairs, Process & System Validations 🔹 Strategic Human Resourcing – Connecting top-tier talent to life sciences and healthcare organizations With deep industry expertise and a flexible, client-centric approach, Katalyst CRO leverages an advise-build-operate model to de-risk and accelerate research programs. We help organizations achieve regulatory success, optimize quality systems, and bring life-changing therapies to market faster—ultimately improving global patient health and safety. 💡 Partner with Katalyst CRO to bring breakthrough therapies to market with confidence. 📩 Let’s connect and shape the future of healthcare together!

Company details

IndustryContract Research Organizations (CRO)
Company size51 - 200

Links

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Job description

Job Summary:
Lead quality remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements. Provide leadership for QMS processes, audit readiness, CAPA governance, quality metrics, and continuous improvement initiatives across cross-functional teams.

Key Responsibilities:

Lead QMS, CAPA, Nonconformance, Complaint, and Audit programs.
Support FDA inspections and regulatory audits.
Drive quality remediation and compliance initiatives.
Monitor quality metrics and management reviews.
Lead cross-functional quality improvement activities.

Required Skills:

Medical Device Quality Management Systems (QMS).
CAPA, Nonconformance, Complaint, and Audit Management.
FDA 21 CFR Part 820/QMSR and ISO 13485.
Risk Management and Design Controls.
Quality Metrics, Remediation, and Compliance Programs.

Preferred Qualifications:

Bachelor's or master's degree in engineering or related discipline.
12+ years of Medical Device Quality experience.
5+ years of Quality Management leadership experience.
ISO 13485 Lead Auditor or ASQ/CQI certification preferred.
Experience supporting FDA inspections and remediation programs

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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